(153 days)
The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.
Not Found
The provided document is a 510(k) FDA clearance letter for the TRUE2go Blood Glucose Monitoring System, and it does not contain the detailed study information needed to answer all aspects of your request. This type of letter confirms the device's substantial equivalence to a predicate device but typically does not include the full study report with explicit acceptance criteria, detailed sample sizes, expert qualifications, or ground truth establishment methods in the way you've outlined for an AI/CAD device.
Blood glucose monitoring systems are generally evaluated based on accuracy against a laboratory reference method, and the acceptance criteria are usually defined by standards like ISO 15197 for in vitro diagnostic medical devices. However, this specific document doesn't provide those details.
Therefore, I cannot provide a complete answer based only on the provided text. I will answer what is inferable from the document and explicitly state what information is missing.
Here's a breakdown of what I can answer and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. For blood glucose meters, these typically relate to the accuracy of readings compared to a laboratory reference method (e.g., specific percentages of readings falling within +/- X mg/dL or +/- Y% of the reference).
- Reported Device Performance: Not explicitly stated in this document. The document confirms market clearance based on substantial equivalence, implying performance met regulatory expectations for blood glucose meters, but specific metrics (e.g., mean absolute relative difference, percentage of readings within certain error margins) are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in this document.
- Data Provenance: Not specified in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- This question is more relevant for diagnostic imaging AI/CAD systems where expert radiologists establish ground truth. For a blood glucose meter, the "ground truth" is typically established by parallel measurements with a highly accurate laboratory reference instrument, not by human expert interpretation. The document does not describe the specific laboratory reference method or setup.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable to a blood glucose monitoring system in the same way it would be for an AI/CAD system relying on expert interpretation. The "adjudication" in this context would be the comparison against the reference method, not a consensus among human interpreters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was not done. This type of study is specific to AI/CAD systems that assist human readers (e.g., radiologists, pathologists). The TRUE2go Blood Glucose Monitoring System is a standalone diagnostic device for quantitative glucose measurement, not an AI assistance tool for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The TRUE2go Blood Glucose Monitoring System is a standalone device. Its performance is measured by its accuracy in providing a glucose reading. The document doesn't detail the specific study, but a standalone performance evaluation against a reference method is fundamental for such a device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for a blood glucose monitor is typically derived from highly accurate laboratory reference methods (e.g., a YSI glucose analyzer or a hexokinase method performed on venous blood plasma/serum). This document does not specify the exact method used.
8. The sample size for the training set
- Not specified in this document. For a physical device like a blood glucose meter, the concept of a "training set" in the context of machine learning (where this question usually applies) isn't directly relevant in the same way. Performance is typically evaluated through clinical studies.
9. How the ground truth for the training set was established
- As above, the concept of a "training set" for a blood glucose meter isn't typically discussed in this context. Device calibration and validation against reference methods are standard, but the document does not detail these processes.
Summary of what is available from the document:
- Device Name: TRUE2go Blood Glucose Monitoring System
- Intended Use: Quantitative determination of glucose in human whole blood (fingerstick or forearm for home use; venous whole blood for healthcare professionals).
- Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
- Not for neonatal use.
- The device is a standalone diagnostic system, not an AI/CAD system designed to assist human readers.
{0}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned above a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 3 2008
Home Diagnostics, Inc. c/o Karen De Vincent Director of Regulatory Affairs/Quality Assurance 2400 N.W. 55th Court Fort Lauderdale, FL 33309
Re: K080710 Trade Name: TRUE2go Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, LFR Dated: August 4, 2008 Received: August 5, 2008
Dear Ms. DeVincent:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{1}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffram mber (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Number (if known): K080710
Device Name: TRUE2go Blood Glucose Monitoring System
Indications for Use:
The TRUE2go Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and Healthcare Professional in the management of diabetes.
Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.
Not for neonatal use.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
の 2006年のモノベーション 2007年08月10日 10:00 【 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVID)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K080710
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.